Crizotinib
Generic name
Crizotinib
Brand name
ATC Code
L01ED01
- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information is present at this moment.
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
Dosages
| ALK-positive anaplastic large cell lymphoma (ALCL); ALK-positive unresectable inflammatory myofibroblastic tumour (IMT) |
|---|
|
Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
In clinical studies with 110 children with various tumor types
Very common (> 10%): neutropenia, anemia, leukopenia, thrombocytopenia. Hypophosphatemia, decreased appetite. Neuropathy, dysgeusia. Vision impairment. Bradycardia, dizziness. Vomiting, diarrhea, nausea, constipation, dyspepsia, abdominal pain. Rise in transaminase levels, rise in alkaline phosphatase in blood. Increase creatinine in blood. Edema, fatigue.
Common (1-10%): QT prolongation. Oesophagitis. Skin rash.
[SmPC]
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Gastrointestinal toxicity: has been reported very frequently in children with ALCL or IMT; vomiting and diarrhea occurred in 95% and 85% of patients, respectively, in clinical trials. Administer antiemetics prior to treatment to prevent nausea and vomiting. Treat gastrointestinal toxicity with antiemetics and antidiarrheal agents. If children develop nausea grade 3 that persists for more than 3 days or diarrhea or vomiting grade 3 or 4 despite maximal therapy, interrupt treatment until symptoms resolve. Resume crizotinib at a lower dose level. Consider supportive treatment, such as hydration and electrolyte supplementation, on clinical indication.
Occurrence of severe vision loss may possibly be due to N. opticus dysfunction. In children with ALCL or IMT, perform an ophthalmic examination prior to treatment, with follow-up (including examination of the retina) within 1 month, and every 3 months thereafter or at new symptoms of vision impairment. If vision impairment is grade 2, monitor the patient and consider dose reduction. Discontinue treatment and have ophthalmologic examination if severe vision impairment (grade 3 or 4) occurs. Insufficient information is available on the recurrence risk with resumption of treatment; weigh the potential benefit to the patient against the risks.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| Anthracyclines and related substances | ||
|---|---|---|
| L01DB02 | ||
| L01DB01 | ||
| L01DB06 | ||
| L01DB07 | ||
| Other cytotoxic antibiotics | ||
|---|---|---|
| L01DC01 | ||
| OTHER MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES | ||
|---|---|---|
| L01FX06 | ||
References
- Pfizer Europe MA EEIG, SmPC Xalkori ( EU/1/12/793/001) Rev 33; 2-12-2022, www.ema.europa.eu
- Pfizer Europe MA EEIG, SmPC Xalkori ( EU/1/12/793/001) Rev 40; 17-09-2025, www.ema.europa.eu
Changes
Therapeutic Drug Monitoring
Overdose
